Sterile Physiological Saline/Sterile Water
FDA 510(k) K943661 · Medcare Custom Packaging, Inc.
510(k) numberK943661
Submission
- Device name
- Sterile Physiological Saline/Sterile Water
- Applicant
- Medcare Custom Packaging, Inc.
E Swanzey, NH, US - Received
- July 28, 1994
- Decision date
- April 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOL – Catheter And Tip, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code JOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051370 | Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014JOL · Traditional | Baxter Healthcare Corp | 08/12/2005SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K000265 | Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | Welcon, Inc. | 05/01/2001SE |
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional | Automatic Liquid Packaging, Inc. | 10/25/2000SE |
| K974759 | Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 ML 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974758 | Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974397 | Sterile Saline for Catheter CareJOL · Traditional | Baxter Healthcare Corp | 02/10/1998SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | Welcon, Inc. | 02/05/1998SE |
| K972372 | Germ Trapper Suction Tube HolderJOL · Traditional | Rzv Medical Specialties, Inc. | 12/11/1997SE |
More from Rzv Medical Specialties, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | 01/19/1996SE |
| K954442 | Sterile Isotonic Saline & Sterile WaterJOL · Traditional | 12/21/1995SE |
| K952759 | Towel PackKKX · Traditional | 09/29/1995SE |
| K950390 | Urethral Catheterization TrayFCM · Traditional | 05/30/1995SE |
| K951149 | Single Use Instrument TrayLRO · Traditional | 04/06/1995SESK |
| K934732 | Pelvic Exam TrayHHT · Traditional | 12/30/1994SE |
| K942000 | Burn Dressing TrayFRG · Traditional | 05/20/1994SESK |
| K936261 | Catheter Insertion TrayFMI · Traditional | 03/10/1994SESK |
| K922179 | Catheter Insertion TrayFMI · Traditional | 07/02/1993SEKD |
| K901856 | Custom Wound Management Kits and TraysLRO · Traditional | 08/01/1990SESD |
Questions and answers
When was Sterile Physiological Saline/Sterile Water cleared by the FDA?
Sterile Physiological Saline/Sterile Water (K943661) received a 510(k) decision of Substantially Equivalent on April 10, 1995, 256 days after the submission was received.
What is the product code of K943661?
The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.